What this pack is
BYSTOLIC is the brand name in this record; nebivolol tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
BYSTOLICGeneric namenebivolol tablets
How this medicine works
The current label describes nebivolol as predominantly beta-1 selective at lower concentrations and notes nitric-oxide-associated vasodilation involving nebivolol and its metabolites. This helps explain effects on heart rate and blood pressure but cannot determine an individual's dose, combination with another rate-slowing medicine or withdrawal/switching.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- BYSTOLIC
- Generic name
- nebivolol tablets
- Dosage-form class
- Nebivolol hydrochloride oral tablets: 2.5 mg, 5 mg, 10 mg and 20 mg; four triangular unscored tablets and exact U.S. bottle identities
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
4 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock
2.5 mg nebivolol per tablet (as hydrochloride); 30-tablet bottle
- Product code
- NDC 0456-1402-30
- Form and route
- BYSTOLIC nebivolol hydrochloride oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- nebivolol (as hydrochloride)
- 2.5 mglabelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion
- Package
- 30 tablets per bottle
- Labelled appearance
- blue · triangular, unscored tablet, approximately 8 mm · imprint 2;1;2;FLUnscored in this labelled presentation
United States label · Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock
5 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle
- Product code
- NDC 0456-1405-90
- Form and route
- BYSTOLIC nebivolol hydrochloride oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- nebivolol (as hydrochloride)
- 5 mglabelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion
- Package
- 90 tablets per bottle
- Labelled appearance
- beige to light brown · triangular, unscored tablet, approximately 10 mm · imprint 5;FLUnscored in this labelled presentation
United States label · Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock
10 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle
- Product code
- NDC 0456-1410-90
- Form and route
- BYSTOLIC nebivolol hydrochloride oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- nebivolol (as hydrochloride)
- 10 mglabelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion
- Package
- 90 tablets per bottle
- Labelled appearance
- purple · triangular, unscored tablet, approximately 10 mm · imprint 10;FLUnscored in this labelled presentation
United States label · Current U.S. DailyMed brand label (SPL v31; label text revised Aug 2024); exact pack identity, not real-time stock
20 mg nebivolol per tablet (as hydrochloride); 90-tablet bottle; FDA RS
- Product code
- NDC 0456-1420-90
- Form and route
- BYSTOLIC nebivolol hydrochloride oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- nebivolol (as hydrochloride)
- 20 mglabelled amount per tablet; not an individual tablet count, switching ratio or beta-blocker conversion
- Package
- 90 tablets per bottle
- Labelled appearance
- blue · triangular, unscored tablet, approximately 10 mm · imprint 20;FLUnscored in this labelled presentation
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
BYSTOLIC label reading: review pulse, abrupt withdrawal and duplicate beta blockers first
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
Check BYSTOLIC, nebivolol, exact strength, NDC and target market, then review low pulse, dizziness/fainting, chest pain, breathing symptoms, diabetes and the complete medicine list together. The four milligram figures are not conversion ratios to another beta blocker.
- 2.5, 5, 10 and 20 mg are labelled nebivolol amounts per tablet. '30' or '90 Tablets' is the bottle count, not the amount per dose. An unscored appearance is an identity clue and does not let the site infer self-splitting permission.
- The label warns against abruptly stopping BYSTOLIC, especially with coronary artery disease, because abrupt beta-blocker withdrawal may worsen angina or myocardial-infarction risk. Do not stop from one pulse or blood-pressure reading; use local emergency care for chest pain or another severe acute symptom.
- If another beta blocker (such as TOPROL-XL, LOPRESSOR/metoprolol, bisoprolol, TENORMIN, INDERAL LA or COREG), digoxin, diltiazem/verapamil or clonidine appears on the list, ask a pharmacist or prescriber to prioritise duplicate effects, heart rate, conduction and hypotension risk.
- The label says nebivolol may mask some warning features of hypoglycaemia; a person with diabetes should not rely only on a racing heart to detect low glucose. Fainting, severe bradycardia, breathing difficulty, swelling of the face/lips/tongue/throat or persistent chest pain requires prompt medical assessment; severe acute features require local emergency care.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-30
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 3
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. BYSTOLIC nebivolol brand label (SPL v31; label text revised Aug 2024) ↗Current regulatory record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- FDA · United States · Regulatory product record or label archive · 2026-08-29FDA Orange Book: all four BYSTOLIC NDA 021742 oral-tablet strengths listed as RLD products; 20 mg also listed as the RS (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA · United States · Regulatory product record or label archive · 2026-08-30FDA Drugs@FDA: official BYSTOLIC NDA 021742 application search entry ↗Current regulatory record · reviewed 2026-08-30
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about BYSTOLIC (nebivolol tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
BYSTOLIC is the brand in this record and nebivolol tablets is the active-ingredient name. Check both with the dosage form (Nebivolol hydrochloride oral tablets: 2.5 mg, 5 mg, 10 mg and 20 mg; four triangular unscored tablets and exact U.S. bottle identities) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. BYSTOLIC nebivolol brand label (SPL v31; label text revised Aug 2024) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book: all four BYSTOLIC NDA 021742 oral-tablet strengths listed as RLD products; 20 mg also listed as the RS (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- FDA Drugs@FDA: official BYSTOLIC NDA 021742 application search entry ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How BYSTOLIC works: primarily beta-1 blockade with nitric-oxide-associated vasodilation
- Sharing the beta-blocker class does not make BYSTOLIC, metoprolol, bisoprolol, atenolol, propranolol and carvedilol one-to-one milligram conversions or medicines to alternate. Ingredient, selectivity, form and label boundaries differ.
- Strong CYP2D6 inhibitors may increase nebivolol exposure; the label gives fluoxetine and paroxetine as examples. Medicine-list review is more useful than relying on a brand name or one blood-pressure reading, and neither psychiatric nor blood-pressure medicine should be self-stopped.
- The label discusses CYP2D6 extensive/poor-metaboliser exposure differences, while noting that clinical importance is usually less than for drugs acting only through the parent compound because active metabolites also contribute. This is not a basis for default whole-genome testing or self-switching from a genetic result.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. BYSTOLIC nebivolol brand label (SPL v31; label text revised Aug 2024) ↗Current regulatory record · reviewed 2026-08-30
- FDA Orange Book: all four BYSTOLIC NDA 021742 oral-tablet strengths listed as RLD products; 20 mg also listed as the RS (data reviewed 30 Aug 2026) ↗reviewed 2026-08-29
- Health Canada: current Drug Product Database (DPD) access page; search BYSTOLIC and its DINs in the database ↗Official lookup entry · reviewed 2026-09-13
- FDA Drugs@FDA: official BYSTOLIC NDA 021742 application search entry ↗Current regulatory record · reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
BYSTOLICnebivolol tablets
This page includes an exact current U.S. public-label package panel for BYSTOLIC, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
FDA approved BYSTOLIC 2.5, 5 and 10 mg
Current Orange Book data connect the three strengths with NDA 021742, prescription RLD status and this approval date.
FDA Orange Book: all four BYSTOLIC NDA 021742 oral-tablet strengths listed as RLD products; 20 mg also listed as the RS (data reviewed 30 Aug 2026) ↗FDA approved BYSTOLIC 20 mg
Current Orange Book data list 20 mg as both RLD and RS. RS is a U.S. regulatory reference-standard field, not an individual preferred-medicine conclusion.
FDA Orange Book: all four BYSTOLIC NDA 021742 oral-tablet strengths listed as RLD products; 20 mg also listed as the RS (data reviewed 30 Aug 2026) ↗U.S. brand label revised
Current DailyMed SPL v31 retains four strengths and prescribing information; this page uses it for package, contraindication, withdrawal, interaction and older-reader boundaries.
DailyMed (NLM): current U.S. BYSTOLIC nebivolol brand label (SPL v31; label text revised Aug 2024) ↗
MARKET SCOPE
Market-record boundary
United States
Four prescription RLD strengths currently listed; 20 mg is the RSThe current label establishes four exact bottle panels. Regulatory listing and label panels do not establish live pharmacy stock or purchasing eligibility.
Canada
All four strengths currently listed as MarketedHealth Canada's DPD lists DIN 02398990, 02399008, 02399016 and 02399024 with AbbVie Corporation. Canadian status is not projected onto the United States or another market.
Mainland China, EU, Japan and other markets
Exact current regulatory product records not establishedNo local approval, brand, supply, originator/reference relationship or interchangeability is inferred from U.S./Canadian names, milligram figures or pack colours.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Is BYSTOLIC the same medicine as metoprolol or bisoprolol?
No. They may share the beta-blocker class, but active ingredients and products differ. Do not self-convert milligrams, alternate by day or duplicate them. Ask the pharmacist or prescriber to review the exact packs and purposes.
Can the medicine be stopped immediately for a slow pulse or dizziness?
A webpage cannot decide withdrawal. The label covers risks such as severe bradycardia and coronary risk from abrupt discontinuation. Record symptoms, pulse, blood pressure and every pack, and contact the responsible team promptly; use local emergency care for fainting, chest pain, breathing difficulty or another severe acute feature.
Is CYP2D6 or whole-genome testing required to use this medicine?
The current label discusses CYP2D6 exposure differences and strong-inhibitor interactions, but does not make whole-genome testing a default prerequisite for everyone. Review the complete medicine list, pulse, kidney/liver function, prior response and clinical question first; the responsible team decides whether a specific test is needed.
Can an unscored tablet be split?
An unscored tablet is an exact-product appearance clue, but the site does not infer splitting permission or prohibition from that fact alone. For swallowing difficulty, strength changes or a damaged tablet, take the exact pack to a pharmacist to review the product label and an appropriate alternative form.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.